Bortezomib in Treating Patients With Diffuse Large B-Cell Lymphoma That Is Refractory To Chemotherapy

Lymphoma Clinical Trial

Official title:

A Phase II Study Of PS-341 (VELCADE) In Chemotherapy-Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00066508
• Other study ID #: CDR0000316254
• Secondary ID: UCLA-0301090
• Status: Completed
• Phase: Phase 2
• First received: August 6, 2003
• Last updated: January 7, 2013
• Start date: May 2003

Study information

• Verified date: January 2013
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Bortezomib may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth.

PURPOSE: Phase II trial to study the effectiveness of bortezomib in treating patients who have diffuse large B-cell lymphoma that is refractory to previous chemotherapy.

Description:

OBJECTIVES:

• Determine the overall response rate in patients with chemotherapy-refractory diffuse large B-cell lymphoma treated with bortezomib.

• Determine the safety and tolerability of this drug in these patients.

• Determine the time to disease progression in patients treated with this drug.

• Determine the possible mechanism of resistance to this drug in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed at 20 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 22-40 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed diffuse large B-cell lymphoma, meeting criteria for 1 of the following:

• Relapsed after prior high-dose chemotherapy with stem cell support

• Relapsed after prior chemotherapy, including at least 1 prior standard non-Hodgkin's chemotherapy regimen, but not a candidate for high-dose chemotherapy with stem cell support

• Measurable disease

• At least 1 bidimensionally measurable lesion at least 1.5 cm by CT scan

• No primary or secondary CNS lymphoma

• No HIV-related lymphoma

• No known brain metastases

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy

• More than 3 months

Hematopoietic

• Hemoglobin at least 9 g/dL

• Absolute neutrophil count at least 1,000/mm^3

• No colony-stimulating factors within 4 weeks before obtaining this result

• Platelet count at least 50,000/mm^3

• No platelet transfusion within 4 weeks before obtaining this result

Hepatic

• Bilirubin no greater than 2 times upper limit of normal (ULN)

• AST and ALT no greater than 2.5 times ULN

• No active hepatitis B or C viral infection

Renal

• Creatinine no greater than 2 times ULN OR

• Creatinine clearance at least 60 mL/min

Cardiovascular

• No myocardial infarction within the past 6 months

• No evidence of acute ischemia or new conduction system abnormalities on EKG

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Sodium greater than 130 mEq/L

• HIV negative

• No ongoing or active infection

• No other concurrent uncontrolled illness that would preclude study participation

• No psychiatric illness or social situation that would preclude study compliance

• No prior allergic reaction attributable to compounds of similar chemical or biological composition to bortezomib

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

• See Chemotherapy

• At least 4 weeks since prior immunotherapy

Chemotherapy

• See Disease Characteristics

• More than 4 weeks since prior chemotherapy

• More than 12 weeks since prior high-dose chemotherapy with hematopoietic stem cell support

Endocrine therapy

• Not specified

Radiotherapy

• More than 4 weeks since prior radiotherapy

• No concurrent radiotherapy

Surgery

• More than 4 weeks since prior major surgery unless fully recovered

Other

• Recovered from prior therapy

• No other concurrent investigational agents

• No other concurrent investigational or commercial agents or therapies to treat the malignancy

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• bortezomib

Locations

Country	Name	City	State
United States	Jonsson Comprehensive Cancer Center at UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (combined complete response and partial response)			No
Secondary	Safety			Yes
Secondary	Tolerability			Yes
Secondary	Time to disease progression			No
Secondary	Possible mechanism of resistance			No